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ENROLLING BY INVITATION
NCT04003311

MDR - Comprehensive Primary/Micro Stem & Versa-Dial Ti Humeral Head

Sponsor: Zimmer Biomet

View on ClinicalTrials.gov

Summary

The objective of this retrospective/prospective enrollment and prospective follow-up consecutive series PMCF study is to collect data confirming safety, performance and clinical benefits of the Comprehensive Primary Micro Stem and Comprehensive Anatomic Versa-Dial Titanium Humeral Heads when used for primary and revision total shoulder arthroplasty (implants and instrumentation) at 1,3,5,7 and 10 years\*. Comprehensive Primary Micro Stem and Comprehensive Anatomic Versa-Dial Titanium Humeral Heads have been on the market since 2007, but have insufficient data to support 10 years of clinical history. Therefore, a prospective aspect to the study will be utilized in order to collect long-term data.

Official title: Comprehensive® Primary Micro Stem and Comprehensive® Anatomic Versa-Dial Titanium Humeral Heads in Primary and Revision Total Shoulder Arthroplasty

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

146

Start Date

2019-12-13

Completion Date

2028-07-29

Last Updated

2025-10-30

Healthy Volunteers

No

Interventions

DEVICE

Comprehensive Primary Micro Stem

Patients that have been implanted with the Comprehensive Primary Micro Stem to repair shoulder malfunction/disease.

DEVICE

Comprehensive Anatomic Versa-Dial Titanium Humeral Head

Patients that have been implanted with the Comprehensive Anatomic Versa-Dial Titanium Humeral head to repair shoulder malfunction/disease.

Locations (4)

Shoulder Clinic of Idaho

Boise, Idaho, United States

Beaumont Health

Royal Oak, Michigan, United States

University of Rochester

Rochester, New York, United States

Department of Orthopaedics & Rehabilitation The Larner College of Medicine at The University of Vermont

Burlington, Vermont, United States